Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1020](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1020) → CKE — Acid Phosphatase, Thymolphthale Inmonophosphate

# CKE · Acid Phosphatase, Thymolphthale Inmonophosphate

_Clinical Chemistry · 21 CFR 862.1020 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE

## Overview

- **Product Code:** CKE
- **Device Name:** Acid Phosphatase, Thymolphthale Inmonophosphate
- **Regulation:** [21 CFR 862.1020](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1020)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K914167](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE/K914167.md) | CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE | Eastman Kodak Company | Mar 17, 1992 | SESE |
| [K915705](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE/K915705.md) | ACID PHOSPHATASE REAGENT SET | Tech Intl. Co. | Feb 27, 1992 | SESE |
| [K873726](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE/K873726.md) | ACID PHOSPHATASE TEST | King Diagnostics, Inc. | Jan 27, 1988 | SESE |
| [K864230](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE/K864230.md) | DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | Nov 28, 1986 | SESE |
| [K860476](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE/K860476.md) | ACID PHOSPHATASE REAGENT SET | Sterling Diagnostics, Inc. | Mar 5, 1986 | SESE |
| [K843380](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE/K843380.md) | ACID PHOSPHATASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | Sep 20, 1984 | SESE |
| [K821526](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE/K821526.md) | ACID PHOSPHATASE REAGENT SET | Anco Medical Reagents & Assoc. | Jun 10, 1982 | SESE |
| [K800693](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE/K800693.md) | STANBIO PROSTATIC ACID PHOSPHATASE TEST | Stanbio Laboratory | Apr 16, 1980 | SESE |
| [K790524](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE/K790524.md) | DATA-ZYME ACIA PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | May 23, 1979 | SESE |

## Top Applicants

- Anco Medical Reagents & Assoc. — 1 clearance
- Data Medical Associates, Inc. — 1 clearance
- Diagnostic Chemicals, Ltd. (Usa) — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Eastman Kodak Company — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKE)

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